VOLUME-PRO: A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT05068609
Collaborator
(none)
509
1
14.2
35.9

Study Details

Study Description

Brief Summary

The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab

Detailed Description

This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.

Study Design

Study Type:
Observational
Actual Enrollment :
509 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
Actual Study Start Date :
Aug 13, 2020
Actual Primary Completion Date :
Oct 18, 2021
Actual Study Completion Date :
Oct 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab

Biological: Nivolumab
Participants in this study are being treated with nivolumab for SCCHN
Other Names:
  • Opdivo®, BMS-936558
  • Outcome Measures

    Primary Outcome Measures

    1. Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth [At enrollment]

      Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)

    2. Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex [At enrollment]

    3. Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity [At enrollment]

    4. Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status [At enrollment]

    5. Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location [At enrollment]

    6. Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations [At enrollment]

    7. Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology [At enrollment]

    8. Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN [At enrollment]

    9. Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis [At enrollment]

    10. Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy [Up to 8 weeks following enrollment]

    11. Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation [Up to 8 weeks following enrollment]

    12. Distribution of doses of nivolumab therapy in participants with R/M SCCHN [Up to 8 weeks following enrollment]

    13. Distribution of subsequent treatment in participants discontinuing nivolumab [Up to 8 weeks following enrollment]

    14. Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN [At enrollment, Up to 8 weeks]

    15. Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN [At enrollment, Up to 8 weeks]

    16. Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN [At enrollment, Up to 8 weeks]

    17. Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN [At enrollment, Up to 8 weeks]

      Cancer Therapy Satisfaction Questionnaire (CTSQ)

    18. Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN [At enrollment, Up to 8 weeks]

      Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)

    • Age ≥18 years at time of nivolumab treatment initiation

    • Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study

    • Charts/records include treatment start date of nivolumab

    • Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion

    Exclusion Criteria:
    • Currently enrolled in an interventional clinical trial for their SCCHN

    • Received systemic treatment for any other primary cancer within 6 months of study enrolment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Mount Laurel New Jersey United States 08054

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05068609
    Other Study ID Numbers:
    • CA209-7F9
    First Posted:
    Oct 6, 2021
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022

    Study Results

    No Results Posted as of May 5, 2022